Force containment in an automatic injector

ABSTRACT

An automatic injector for delivering a pharmaceutical substance from a reservoir of a cartridge, the cartridge interconnected to a needle at its distal end and mechanically coupled to a plunger driver at its proximal end, the injector comprising a connecting feature on the cartridge a contact surface for contacting an injection site a frame connected to the contact surface, the frame having an interference element with a distal stop, the interference element sized to slidably link to the connecting feature and allow the cartridge to slide up to the distal stop, a snap element allowing the interference element to receive the connection feature, but inhibiting disconnection of the cartridge; the frame further comprising a driver mount, for fixedly containing a plunger driver, the driver for driving a plunger to empty the reservoir of the cartridge through the needle to inject fluid from the reservoir into the injection subject.

RELATED APPLICATION

This application is a divisional application of similarly-titled,co-pending U.S. application Ser. No. 16/071,574, filed Jul. 20, 2018,which is a section 371 of International Application No. PCT/US16/68371,filed Dec. 22, 2016, which was published in the English language on Jul.27, 2017 under International Publication No. WO 2017/127216 A1, whichclaims the benefit of U.S. Provisional Application No. 62/281,536, filedJan. 21, 2016, the disclosures of each which are incorporated herein byreference in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to automaticinjectors and, more particularly, but not exclusively, to forcecontainment in automatic injectors.

U.S. Pat. Nos. 6,500,150, 6,824,529, and 6,843,782 disclose a drugdelivery device having a base member defining a skin-contacting surface,a syringe serving as a reservoir for the drug, and means for expellingdrug from the syringe. The syringe is connected to the base member suchthat the longitudinal axis of the syringe is substantially parallel tothe skin surface. A delivery needle is in communication with thesyringe. The needle has an angled bend which directs the tip of theneedle substantially perpendicular to the skin-contacting surface. Inuse, the tip of the needle is adapted to penetrate the skin of thesubject.

For such relatively slow release, an automatic expulsion device has alsobeen suggested. U.S. Pat. No. 5,858,001 discloses a liquid drug deliverydevice adhered to the skin of a subject by a base member defining askin-contacting surface having an adhesive coating. A columnar cartridgeserves as reservoir for the drug and is incorporated in a housing whichis connected to the base member such that in use the longitudinal axisof the cartridge is disposed substantially parallel to theskin-contacting surface. A delivery needle communicating in use with theinterior of the cartridge penetrates the skin of the subject when thehousing snaps downward relative to the base member. This action alsocauses the actuation of a citric acid/sodium bicarbonate gas generatorwhich generates a gas to move a piston within the cartridge, compressingthe drug compartment. This compression causes a stopper to be penetratedby a conduit in communication with the delivery needle, allowing thedrug to be ejected from the compartment through the needle and into thesubcutaneous tissue of the subject.

Additional background art includes U.S. Pat. No. 6,189,292. U.S. PatentPublication No. 20130253434, U.S. Patent Publication No. 2009/0093792,U.S. Pat. No. 7,967,795.

SUMMARY OF THE INVENTION Example 1

An automatic injector for delivering a pharmaceutical substance from areservoir of a cartridge, the cartridge interconnected to a needle atits distal end and mechanically coupled to a plunger driver at itsproximal end, the injector comprising a connecting feature on thecartridge; a contact surface for contacting an injection site a frameconnected to the contact surface, the frame having: an interferenceelement with a distal stop, the interference element sized to slidablylink to the connecting feature and allow the cartridge to slide up tothe distal stop, a snap element allowing the interference element toreceive the connection feature, but inhibiting disconnection of thecartridge; the frame further comprising a driver mount, for fixedlycontaining a plunger driver, the driver for driving a plunger to emptythe reservoir of the cartridge through the needle to inject fluid fromthe reservoir into the injection subject.

Example 2

The automatic injector of example 1, wherein the frame is unitary.

Example 3

The automatic injector of example 1, wherein the frame comprises a motormount, for fixedly containing a motor in operable communication with theplunger driver.

Example 4

The automatic injector of example 3, wherein the motor, the driver andthe reservoir having longitudinal axes positioned on the same plane.

Example 5

The automatic injector of example 1, wherein the frame is positioned ina proximal portion of the housing.

Example 6

The automatic injector of example 1, wherein the frame is suitable forreducing translational movement of the cartridge.

Example 7

The automatic injector of example 1, wherein the frame is suitable forreducing rotational movement of the cartridge.

Example 8

The automatic injector of example 1, wherein the driver mount comprisesa walled container having a top opening.

Example 9

The automatic injector of example 8, further comprising a top coverhaving at least one extension complementing at least one gap in thewalled container.

Example 10

The automatic injector of example 9, wherein the top cover comprises anextension sized to fit between a gap in a proximal wall of the walledcontainer and a proximal portion of the plunger driver, once the plungerdriver slides in a distal direction.

Example 11

A receiving frame for immobilizing a cartridge having a connectionfeature to an automatic injector housing, the cartridge having a needleat its distal end, and is mechanically coupled in its proximal end to aplunger driver, comprising a ventral side for fitting into a baseportion of the automatic injector; and a dorsal side having: a cartridgemount for receiving the cartridge from above, the cartridge mountcomprises a interference element with a distal stop, the interferenceelement sized to slidably link to the connection feature and allow thecartridge to slide up to the distal stop, and a snap element allowingthe interference element to receive the connection feature, butinhibiting disconnection of the cartridge; and a driver mount, forfixedly containing the plunger driver, the driver mount comprising awalled container sized to at least partially surround the plunger driverand having an open top for receiving the plunger driver from above;wherein the cartridge and the driver are mechanically coupled throughthe plunger.

Example 12

The receiving frame of example 11, further comprising a motor mount, forfixedly containing a motor in operable communication with the plungerdriver, the motor mount comprising a walled container sized to at leastpartially surround the motor and having an open top for receiving themotor from above;

Example 13

The receiving frame of example 11, wherein the cartridge mount, thedriver mount and the motor mount are made of a unitary piece.

Example 14

The receiving frame of example 11, wherein longitudinal axes of thecartridge, the plunger driver and the motor are positioned on the sameplane.

Example 15

The receiving frame of example 11, wherein the driver mount containsforces of at least 20 Kg*cm.

Example 16

The receiving frame of example 11, wherein the interference fit isshaped to surround a portion of the cartridge from a dorsal, a distaland a ventral side of the cartridge portion.

Example 17

A method of connecting a cartridge having a connection feature to anautomatic injector having a motor, the cartridge interconnected to aneedle at its distal end and mechanically coupled to a plunger driver atits proximal end, comprising lowering the cartridge while beingmechanically coupled with the plunger driver into a receiving frame ofthe automatic injector, the receiving frame having an open top; slidingthe cartridge in a direction of the distal end until reaching a distalstop; linking the connection feature to an interference element of thereceiving frame; snapping the connection feature, such thatdisconnection of the cartridge is inhibited; and containing forcesgenerated by the plunger driver on the cartridge through the receivingframe, thereby immobilizing the cartridge with respect to the automaticinjector.

Example 18

The method of example 17, wherein the containing forces comprisesmechanically interfering with an axial translation of the cartridge.

Example 19

The method of example 17, wherein the containing forces comprisesmechanically interfering with a rotational translation of the cartridge.

Example 20

The method of example 17, wherein the interlocking comprises surroundinga portion of the cartridge from at least four directions being a dorsalside, a ventral side, a proximal side and a distal side.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a block diagram schematically representing an automaticinjector receiving frame for fitting with a cartridge and a drivingsystem of the cartridge, in accordance with some embodiments of theinvention;

FIG. 2 is a high level overview of a method for immobilizing movement ofa cartridge with respect to an automatic injector assembly, inaccordance with some embodiments of the invention;

FIG. 3A is an exemplary unitary receiving frame illustrating a distaland proximal geometry for fitting with and immobilizing components of anautomatic injector, in accordance with some embodiments of theinvention;

FIG. 3B is an exemplary unitary receiving frame fitted with variouscomponents of an automatic injector, in accordance with some embodimentsof the invention;

FIG. 4 is an exemplary cartridge having distal and proximal mountingpins for connecting with a receiving frame, in accordance with someembodiments of the invention;

FIG. 5 is an explosive view of an automatic injector being loaded with acartridge and covered with a cover, in accordance with some embodimentsof the invention;

FIG. 6 is a close-up cross-sectional view of an exemplary geometry andinterference connection of a proximal portion of a unitary receivingframe with a proximal portion of a cartridge, in accordance with someembodiments of the invention;

FIG. 7 is a perspective top view of an exemplary side-by-sideconfiguration of the cartridge and the driving system of the cartridge,in accordance with some embodiments of the invention;

FIGS. 8A and 8B illustrate a side view of a snap fitting andimmobilization of a cartridge, in accordance with some embodiments ofthe invention, wherein FIG. 8A illustrates a cross-sectional view ofFIG. 8B illustrates a partial perspective view;

FIG. 9 is a cross-sectional side view of the automatic injector,illustrating an incorporation of a cover extension in the immobilizationsystem, in accordance with some embodiments of the invention; and

FIG. 10 illustrates a bottom perspective view of an exemplary unitaryreceiving frame, showing a distal fitting with a cartridge, inaccordance with some embodiments of the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to automaticinjectors and, more particularly, but not exclusively, to forcecontainment in automatic injectors.

Overview

An aspect of several embodiments of the invention relates toimmobilizing a cartridge with respect to an automatic injector mountingplate, the mounting plate used for mounting over an injection subject.In some embodiments, immobilizing includes reducing axial translation ofthe cartridge, for example, axial translation of the cartridge towardsthe distal end of the mounting plate, defined as the end comprising aninjection needle, and/or axial translation of the cartridge towards theproximal end of the mounting plate, defined as the end comprising aplunger. Alternatively or additionally, immobilizing comprisesinhibiting rotational movement of the cartridge, for example, movementin the form of rotation around the longitudinal axis of the cartridge.

In some embodiments, it is desirable that the cartridge is immobilizedin the injector sufficiently that operating the plunger mechanism toexpel the contents does not move the cartridge. If the cartridge were tomove then the needle may cause discomfort to the patient in the skinaround the needle. This is especially relevant for a cartridge having abent fluid path, which translates any rotational movement of thecartridge into an axial translation movement of the elongated axis ofthe needle.

In order to provide such immobilization, in some embodiments, areceiving frame is provided within the injector mounting plate toreceive the cartridge. Optionally, the cartridge is fixedly received,i.e. while the cartridge is received it is also fixed to the receivingframe. For example, fixed includes immobilizing movement of more than0.1 mm, and/or more than 0.5 mm, and/or more than 1 mm, and/or more than2 mm, and/or more than 4 mm. In some embodiments, the receiving frameengages the cartridge such that forces exerted on the cartridge, forceswhich might cause its translation and/or rotation, are sufficientlyreduced. Alternatively or additionally, the receiving frame is providedto contain force generated by components which are mechanically coupledto the cartridge. In some embodiments, the cartridge is mechanicallycoupled to a plunger driver, optionally by having a driving system whichis mechanically connected to a plunger residing within the reservoir ofthe cartridge. In some embodiments, the plunger driver is found in amechanical operable communication with a motor, optionally through atransmission system. Optionally, forces generated by the motor, and/orby the plunger driver are contained within the receiving frame. In someembodiments, a single frame is used for fixedly receiving the cartridgeand its associated plunger driver and/or motor.

Optionally, the receiving frame is formed as a unitary frame. As usedherein, unitary includes being formed and/or molded as a single unit,without having more than one component. It should be noted that having aplurality of components being interlocked to form a single unit, are notincluded herein in the scope of the term unitary. In order to avoidmovement of the distal portion of the cartridge, where the needle ispositioned, it is preferable to dissipate forces near their source, e.g.the proximal portion comprising the motor and driving system.Alternatively or additionally, it is useful to utilize a receiving framehaving as little as possible different parts, such as no more thanthree, or no more than two, or no more than one unitary frame.

In some embodiments, the receiving frame comprises a dorsal side forfixedly receiving at least the cartridge, and a ventral side for placingonto a mounting plate. Optionally, the receiving frame is hingelyconnected to the mounting plate, optionally at its sides. In someembodiments, it is desirable that the injector housing would have asmall height, potentially enabling easier gripping. In some embodiments,the height may be reduced by positioning of the cartridge, the drivermount and the motor in a side-by-side arrangement, for example bypositioning the longitudinal axes of each of the cartridge, the plungerdriver and the motor on the same plane, optionally, parallel to theplane defined by the base of the housing, and/or the plane used formounting on the injection subject.

In some embodiments, the receiving frame comprises at least oneinterference element which has a geometry for holding the cartridge. Insome embodiments, the interference element engages with a connectionfeature, such as for example a complementary geometry, comprised in thecartridge. For example, the interference element may include holdersinto which complementary geometry in the form of extensions on the bodyof the cartridge can slide into. In some embodiments, the cartridge andits complementary geometry slide towards the distal end of the housing,up to a distal stop. Optionally, the complementary geometry is thenlatched at a final resting position by a catch located behind, so thatthe cartridge can be inserted with a down, slide and click operation. Asused herein, an interference element includes a restraining geometry forengaging with a connection feature of the cartridge, for example, byenveloping the connection feature from three directions, or beingenveloped by the connection feature in three directions.

Alternatively or additionally, the cartridge may include a complementarygeometry in the form of flange and/or cut out and/or bevel and/or anindentation and/or a protrusion and/or a pin and/or a stabilizer and/ora hole and/or a snap fitting and/or hook and/or a pin designed to matewith the fitting of the interference element of the receiving frame.Optionally, the interference element includes a flange and/or cut outand/or bevel and/or an indentation and/or a protrusion and/or a pinand/or a stabilizer and/or a hole and/or a snap fitting and/or hookand/or a pin.

In some embodiments, a non-symmetric cartridge is provided. Optionally,loading the non-symmetric syringe into a device in the correctorientation requires reference points and/or connection features. Insome embodiments, the fitted geometry of the interference elements withthe complementary geometry of the cartridge serves as reference points.

In some embodiments, interference elements are sized and shaped toaccommodate three sides of the complementary geometry, optionally thedorsal side, the ventral side and the distal side, resulting in a holderwhich holds the complementary geometry in three directions.Alternatively, it is the complementary geometry which surrounds theinterference element, optionally across the dorsal side, the ventralside and the proximal side. In some embodiments, mechanicallyinterfering across the dorsal and ventral portions of the complementaryelements mechanically hinders their movement. In some embodiments, atleast two interference elements are provided in opposite locationspositions along the longitudinal axis of the cartridge, each positionedat an opposite location across the cartridge reservoir. Potentially,providing mechanical interference in at least two locations positionedacross the circular diameter of the cartridge reduces rotationalmovement.

In some embodiments, after the cartridge slides to be engaged with theinterference elements, up to the distal stop, an elastic element closesa fourth side of the cartridge. For example, a snap may be elasticallypushed down when lowering the cartridge into the receiving frame, andonce the cartridge slides towards the distal end, the elastic element isreleased and secures the cartridge from a fourth side, such as theproximal side. Optionally, the elastic element is a snap. In someembodiments, at least two snaps are provided, each securing anengagement of at least two interference elements with complementarygeometries. In some embodiments, securing the complementary geometry ofthe cartridge from the distal end, such as by the distal stop, and fromthe proximal end, such as by the elastic element, reduces movement in alateral, axial translocation.

In some embodiments, the receiving frame is configured to hold theproximal side of the cartridge and the plunger driver together. In someembodiments, the walled driver mount balances rearward forces of theplunger driver while the interference elements balance longitudinalforces between the plunger driver and the cartridge. In someembodiments, torque formed between the transmission, the plunger driverand the cartridge is directed to the proximal portion of the receivingframe. In some embodiments, the interference elements and the walledcontainments prevent movement in a distal direction, in an upwardsdirection or in a rotation around the axis of the cartridge. In someembodiments, the proximal elastic element prevents the cartridge frommoving proximally and also prevents the cartridge from beingdisconnected from the receiving frame.

In some embodiments, the receiving frame comprises a distalcomplementary element for engaging and stabilizing a distal portion ofthe cartridge near the needle. In some embodiments, the cartridgecomprises a bent fluid path extending from a dorsal outlet and bendingtowards the ventral side of the cartridge. In some embodiments, thedistal complementary element is positioned on the free ventral side ofthe cartridge. In some embodiments, when the distal complementaryelement is engaged with the receiving frame, forces emanating from theneedle, such as from usage of the needle or from delivery shocks, aredissipated. For example, a distal portion of a cartridge might have hasan elongated protrusion, extending beyond the edge of the cartridge, andbeing complementary to slide into a hole provided in the receivingframe. In some embodiments, distal connectors hold the needle steadyagainst vertical forces of needle insertion or lateral forces againstthe needle. In some embodiments, the fitting geometry also preventsforward movement in the axial direction. In some embodiments, the distalpin is within the cross section of the cartridge and does not interferewith a process for filling the cartridge.

In some embodiments, the cartridge itself comprises complementarygeometry elements for fitting with geometric elements in the receivingframe. In some embodiments, a cross-section across a reservoir of thecartridge lacks an axial symmetry, for example, it is not round.Alternatively or additionally, the cross-section across a reservoir ofthe cartridge has a central symmetry, for example, by having ageometrical element on either side of the reservoir. In someembodiments, the cartridge is manufactured by molding, optionallyCrystal Zenith. A potential advantage of molding is the possibility tobuild into the cartridge geometric features which make the syringeeasier to mount in an injection device. Alternatively or additionally,the syringe may include a molded component. Optionally the moldedcomponent includes the extension. For example the molded component maybe made of Daikyo Resin CZ (Crystal Zenith) or other Cyclic OlefinPolymer (COP) or any moldable material suitable to use with drugproduct. Alternatively or additionally, molded components may be madeof, for example, polycarbonate and/or polypropylene and/or otherpolymers.

An aspect of some embodiments of the invention relates to a receivingframe to be fit within of an automatic injector, optionally within aproximal portion, and for containing forces generated between a motor, aplunger driver and a cartridge comprising the plunger. In someembodiments, a unitary frame is provided having at least two mountcontainments, one for each of the plunger driver and the cartridge. Insome embodiments, the unitary frame is further provided with a thirdmount containment for the motor. Optionally, the unitary frame compriseswalls for containing and dissipating the forces emanating from each ofthe motor and/or the plunger driver.

In some embodiments, the receiving frame is configured to receive fromabove a cartridge being mechanically coupled to the plunger driver.Optionally, the cartridge is mechanically coupled to the plunger driverthrough a plunger which resides within the reservoir of the cartridgeand is mechanically connected to at least one arm of the plunger driver.In some embodiments, the plunger driver comprises a driving assembly,optionally a telescopic system. For example, the plunger driver mayinclude threaded telescoping rods such that when a transmission isrotated (for example by a motor) the telescoping rods expand the plungerinto the reservoir possibly causing discharge of a pharmaceuticalsubstance out of the cartridge fluid path.

Alternatively, the receiving frame is configured to receive from above acartridge being mechanically coupled to the plunger driver and to themotor, for example, through a transmission mechanically coupling anoperative communication between the motor and the plunger driver.

In some embodiments, the mount containments of the receiving framecomprise an open top, allowing the lowering of the cartridge and itsassociated components into the receiving frame from above. In someembodiments, the geometry of the receiving frame is configured to allowlateral sliding of the cartridge with the plunger driver, for exampletowards the distal end of the receiving frame.

For automatic operation, in some embodiments, an electric motor isprovided to operate the plunger. In order to lower the profile of thedevice so that it is easy to hold flat and still against the skin, themotor is in some embodiments placed along an axis that is on the sameplane as an axis of the cartridge. Optionally, the motor and thecartridge/plunger axes are parallel to each other. Further optionally,both are substantially perpendicular to the axis of injection into theskin, for example, when the cartridge comprises a bent fluid path.

In some embodiments, a cartridge mount is provided in the receivingframe for receiving the cartridge from above. Optionally the cartridgeis fixed to the receiving frame after it is lowered into the receivingframe. Alternatively, the cartridge is fixed to the receiving framewhile it is being lowered into the receiving frame. As used herein,fixed to the receiving frame relates to restraining the cartridge inplace, for example inhibiting its movement for more than 0.1 mm, and/ormore than 0.5 mm, and/or more than 1 mm, and/or more than 2 mm, and/ormore than 4 mm. In some embodiments, the cartridge mount comprises theinterference element with the distal stop, the interference elementsized to slidably receive the cartridge and allow the cartridge to slideup to the distal stop.

In some embodiments, a driver mount is provided in the receiving framefor fixedly containing the driver mount. In some embodiments, the drivermount comprises a walled compartment, at least partially surrounding theplunger driver. In some embodiments, the close proximity of the walls ofthe compartment to the plunger driver causes forces generated in theplunger driver to dissipate, such that forces that might reach thecartridge are reduced.

In some embodiments, the walled containment of the driver mountcomprises a gap in its proximal end, sized to accommodate a proximalportion of the driver plunger. Optionally, the gap assists ineliminating mechanical interference when lowering the cartridge with thedriver plunger into the receiving frame. In some embodiments, once thecartridge and its associated driver plunger are shifted towards thedistal side of the housing, the gap no longer accommodates the driverplunger. Optionally, a housing top cover comprises an extension sizedand/or shaped to fit between the gap and the proximal portion of theplunger driver. Optionally, the cover extension serves as an additionalsupporting wall, aiding in the force dissipation of the driver mount.

In some embodiments, a motor mount is provided in the receiving frame tocontain the motor and dissipate forces generated by the motor. In someembodiments, the motor mount comprises an open top for receiving themotor from above. Optionally, the motor mount comprises at least twowalls, optionally oppositely positioned, sized to fit over the motorsides, optionally its longitudinal sides. In some embodiments, the wallscomprise a rail for slidably guiding and securing the receiving of themotor.

Optionally, the receiving frame is provided with a transmission mount.In some embodiments, the transmission mount is positioned between themotor mount and the plunger driver mount. In some embodiments, thetransmission mount comprises an elongated rod configured for fittingwith a center of a wheeled transmission system.

In some embodiments, the driver mount and/or the motor mount aresuitable for containing forces of at least 10 Kg-cm, or at least 15Kg-cm, or at least 20 Kg-cm, or at least 25 Kg-cm.

An aspect of some embodiments of the invention relates to forcecontainment between a cartridge having a bent fluid path and anautomatic injector apparatus. In some embodiments, force containmentcomprises reducing movement of a needle of the cartridge with respect tothe injector base, which might arise from force exerted on thecartridge, for example, when driving fluid out of the cartridge. In someembodiments, an injector base is provided with a unitary mounting framehaving interfering geometry for fitting with the cartridge, optionallyat least for fitting with a distal portion of the cartridge and aproximal portion of the cartridge.

In some embodiments, the unitary frame is configured to contain forcesalong a longitudinal axis of the cartridge. Specifically, in someembodiments, the high forces between the plunger driver system and theplunger are dissipated. Typically, relatively high forces may be exertedon the cartridge by the plunger driving system, for example, about 3-4Kg. High forces may cause instability of the cartridge which may lead tomovement and/or breakage of the cartridge.

Alternatively or additionally, the unitary frame is configured tocontain rotational forces. In some embodiments, the cartridge isconnected to the needle at an angle, resulting in a configuration whichis sensitive to both lateral and rotational movements of the cartridge,where small movements (rotation and/or translation) of the syringe maycause pain to the user or failure of the device. This is as opposed tosyringes having a straight needle, which typically are not sensitive toa rotational displacement.

In some embodiments, the unitary frame structure is designed to create alocal force balance at cartridge locations prone to impact, for example,at the distal end of the cartridge comprising the needle, where force isexerted when the needle is being pushed into a user's body, and/or atthe proximal end comprising the plunger driving assembly, where forcesare exerted on the plunger in order to drive fluid out of the cartridge.A potential advantage of using a unitary frame for containinglongitudinal force along an axis is the durability of the frame towithstand the forces exerted by the injector operation, potentiallyreducing breakage and/or disassembly, which might arise in a pluralityof interconnected components. Often longitudinal forces are balanced ondifferent parts and/or at different ends of the syringe. For example,proximal plunger driving forces may be absorbed by a door at theproximal end, while a distal force against the cartridge may be absorbedby the injector housing at the front of the injector. This may causeinstability of the injector and/or cause high forces on joints betweenparts.

An aspect of some embodiments of the invention relates to a low profilepatch auto injector. In some embodiments a low profile patch autoinjector may include a frame fitted to accommodate a cartridge. In someembodiments, the frame is walled. In some embodiments, the frame ispivotly connected at the front, distal end (needle end) of the injectorto a base. In some embodiments the injector includes a cover. In someembodiments, the syringe in the cartridge is symmetric. In someembodiments, the syringe in the cartridge is non-symmetric. In someembodiments the frame includes a receiving frame that supports thecartridge.

In some embodiments, at least a portion of the walled frame is floored.In some embodiments, the height of the frame wall varies at differentlocations. In some embodiments, the wall is continuous throughout itscircumference. In some embodiments, the wall is discontinuous inportions of its circumference. In some embodiments, the cover fits overthe frame wall. In some embodiments, the cover walls follow and parallelthe frame wall. In some embodiments, the cover wall covers missingportions of the frame wall. In some embodiments, the cover includes aremovable central section. In some embodiments, the cover centralsection includes a wall that parallels a portion of the cover wallforming a double wall at that location.

An aspect of some embodiments of the invention relates to a receivingframe that supports the cartridge. In some embodiments, the receivingframe includes a stress containment enclosure. In some embodiments, thestress containment enclosure mechanically mediates stress effected onthe frame by the syringe and vice versa. In some embodiments theenclosure includes a portion of the injector cover. In some embodiments,the stress containment enclosure steadies and stabilizes the cartridge.In some embodiments, the receiving frame includes means for supportingthe cartridge. In some embodiments, the receiving frame includescoupling mechanisms to attach the cartridge thereto. In someembodiments, the coupling mechanism includes the injector cover. In someembodiments the cartridge includes gripping members. In someembodiments, the receiving frame-cartridge coupling mechanisms functionas guides and guide a cartridge being mounted to its correct finallocation on the receiving frame. In some embodiments the receiving framesupports the injector syringe plunger driving power train.

In some embodiments, the receiving frame supports a printed circuitboard (PCB). In some embodiments, the receiving frame supports coverlocking/unlocking mechanism. In some embodiments, the receiving frameprovides structural support to the frame.

The cartridge may be pre-filled in a sterile aseptic environment usingstandard equipment for filling syringes prior to insertion in theinjector. The injector itself need not be sterile. As the needle ismolded into the cartridge it is desirable that the cartridge isimmobilized in the injector sufficiently that operating the plungermechanism to expel the contents does not move the cartridge. If thecartridge were to move then the needle may cause discomfort to thepatient in the skin around the needle. In order to provide suchimmobilization, there may be provided a clip that fits within theinjector and which has a catch mechanism for holding the cartridge. Thecatch mechanism may include bridge holders into which extensions on thebody of the cartridge can slide and then be latched at a final restingposition by a catch located behind, so that the cartridge can beinserted with a down, slide and click operation.

The injector may provide for insertion of the needle by a simple actionof pressing by the user, whether patient or medical personnel when theinjector is located on the skin. The needle cover is removed, theinjector is placed on the skin and a button is pressed.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Cartridge Immobilization Block Diagram

Referring now to the drawings, FIG. 1 shows a block diagram representingan automatic injector mounting frame for fitting with a cartridge and adriving system of the cartridge, in accordance with some embodiments ofthe invention.

In some embodiments, an automatic patch injector is mounted on aninjection subject. In some embodiments, the automatic injector comprisesmounting plate 101. In some embodiments, mounting plate 101 is used forholding the device and for containing the internal components of theinjector, such as cartridge 120 having needle 116 at its distal end 104and plunger 141 at its proximal end 106. In some embodiments, cartridge120 comprises a reservoir, optionally filled with a pharmaceuticalsubstance. As used herein, a pharmaceutical substance comprises anyfluid used for injecting into an injection subject, such as a drug, aplacebo, a nutrient and so forth.

In some embodiments, mounting plate 101 comprises receiving frame 110for fixedly containing at least some of the internal components of theautomatic injector. Optionally, receiving frame 110 is unitary, i.e.made from a single piece of material. In some embodiments, receivingframe 110 comprises a ventral side for fixing with mounting plate 101and/or the injector's base portion, and a dorsal side having geometryfor containing internal injector components.

In some embodiments, forces are generated by motor 170 and transmittedto plunger driver 140, optionally through a transmission system. In someembodiments, large forces, for example 3-5 Kg, are generated by plungerdriver 140 when driving plunger 141 inside cartridge 120. In order toeliminate forces over the longitudinal axis of the cartridge, whichmight give in and break, in some embodiments forces are dissipated byreceiving frame 110 in proximity to their generation site.

In some embodiments, receiving frame 110 comprises geometries forfixedly containing force generating components and/or force affectedcomponents. For example, receiving frame 110 may comprise the drivingsystem of the injector which includes at least a cartridge mount forfixedly receiving cartridge 120, a driver mount for containing plungerdriver 140 and a motor mount for containing motor 170. In someembodiments, forces are locally balanced. In some embodiments, receivingframe 110 comprises geometry which contains the components of thedriving system of the injector in proximity to one another, for examplein proximal end 106. A potential advantage of containing force exertingand exerted components in proximity is that forces may be dissipatedclose to where they are generated and/or affecting, without beingprojected to other regions of the injector. Another potential advantageof a limited space for containing force is that force containingstructures in receiving frame 110 are provided at the limited region,reducing redundancy of structures.

In some embodiments, receiving frame 110 comprises a platform, e.g. aplaner structure. In some embodiments, the components of the drivingsystem, at least cartridge 120, plunger driver 140 and motor 170, arecontained side-by-side over the platform, optionally each of thecomponents are placed along their longitudinal axis. In someembodiments, the longitudinal axes of cartridge 120, plunger driver 140and motor 170 are positioned on the same plane, and/or parallel planes,optionally additionally parallel to the injector base plane. A potentialadvantage of placing the longitudinal axes laterally on substantiallythe same plane is limiting the height of the housing and injectordevice, possibly making it easier to be held by hand, and easier totransport.

High Level Overview of Cartridge Immobilization

Reference is now made to FIG. 2, showing a high level overview of amethod for immobilizing movement of a cartridge with respect to anautomatic injector housing, in accordance with some embodiments of theinvention.

In some embodiments, a housing is provided 202 having within it areceiving frame. In some embodiments, the receiving frame serves as achassis, containing the internal components of the injector. In someembodiments, a cartridge is lowered 204 into the receiving frame fittedwithin the housing from above. Optionally, the cartridge is loweredwhile being mechanically coupled to a plunger driver. In someembodiments, mechanical coupling between the cartridge and the plungerdriver comprises an arm, optionally telescopically extended, whichmechanically connects to a plunger residing within the reservoir of thecartridge. Alternatively or additionally, the cartridge may be loweredinto the receiving frame while being mechanically coupled to a motor,the motor being in operable mechanical communication with the plungerdriver, optionally through a transmission system.

In some embodiments, the cartridge, and possibly its associatedcomponents, is being laterally moved by sliding 206 towards the distalend of the receiving frame, defined as the end fitting with the distalportion of the cartridge, which comprises the needle outlet. In someembodiments, by sliding the cartridge in 206, the cartridge isinterlocked 208 with the receiving frame, optionally by engaging withgeometry provided in the receiving frame, such as interference elementsand/or snap latches. A potential advantage of activating engagement bypositional translocation into a fitting geometry is that it enables adelicate interlocking mechanism, i.e. a mechanism which requires a smallamount of force to apply, as opposed to a mechanism of elastic fittingwhich operates on the basis of first pushing away the interferingelement, instead of sliding into it.

In some embodiments, the cartridge is lowered down from above whilebeing mechanically coupled with the driving system of the injector, e.g.the plunger driver and/or the motor. In some embodiments, the receivingframe contains walled compartments for receiving the coupled componentsof the cartridge. In some embodiments, the walled compartments are notuniform in wall height, for example having gaps, and enable someportions of the driving system to extend beyond the boundaries of thewalled compartments. Optionally, by sliding 206 the cartridge into itsinterlocked position, the driving system components extending beyond theboundaries are shifted to be positioned as a whole inside the boundariesof the walled compartments. In some embodiments, a space is formedbetween the wall having the gap and the driving system components.

Optionally, the receiving frame is covered 210 with a housing cover. Insome embodiments, the housing cover complements gapped regions in thewalled compartments of the receiving frame. In some embodiments, thehousing cover comprises extensions sized and/or shaped for fitting inthe space between the wall and the shifted component. In someembodiments, the filling in of the extension provides mechanical supportfor the components, aiding in the dissipation of the force emanatingfrom the components. For example, being mechanically connected to theplunger, the plunger driver may be found in a proximal position to thecartridge. A gap in the walled compartment containing the plunger driverenables the proximal portion of the plunger driver to extend beyond theboundary of the wall. When the cartridge is shifted distally by sliding,so does the coupled plunger driver. By shifting distally, the plungerdriver may now be fully contained within the compartment.

However, the remaining gap may lead to insufficient containment offorces which cause the plunger driver to shift towards a proximaldirection. Filling this space with the cover, may provide a supportingwall that would balance these forces, reducing movement of the plungerdriver. In some embodiments, the plunger driver delivers 212 fluid byextending a threaded telescopic extension towards the distal direction,where the plunger is with respect to the plunger driver. The plunger isthen pushed towards the distally located outlet comprising the needle,driving the fluid out of the cartridge. Providing the proximal supportin the form of the walled compartment, provides an anchoring pointenables the extending arm to push the plunger distally, against thepressure of the fluid, rather than having the plunger driver beingpushed proximally.

Exemplary Unitary Mounting Frame

Reference is now made to FIG. 3A, illustrating an exemplary unitarymounting frame illustrating a distal and proximal geometry for fittingwith and immobilizing components of an injector, in accordance with someembodiments of the invention.

In some embodiments, receiving frame 110 comprises two regions ofgeometric fitting, a proximal region and a distal region. In someembodiments, a distal region secures the distal portion of cartridge 120by distal mount 325, exemplified and illustrated, for example in FIG. 4,showing the distal mounting pin 422 of cartridge 120 and FIG. 10 showingthe distal mount engaged with the distal mounting pin 422 of cartridge120. In some embodiments, a proximal region of receiving frame 110comprises the proximal force generating components of the injector. Insome embodiments, the two regions are positioned on floor 111 ofreceiving frame, which is optionally not continuous between the regions,as exemplified and shown in FIG. 10. In some embodiments, floor 111 issubstantially flat and serves as a base on which the complementarygeometries of receiving frame 110.

In some embodiments, a proximal portion of receiving frame comprises acartridge mount 327, a plunger driver mount 315 and a motor mount 317.Optionally, all mounts are found in proximity to one another,potentially dissipating forces near their generation sites and reducingforces propagation into less secured components and regions. In someembodiments, each mount contains geometric features which are sized andshaped to contain the injector components. Optionally, the receivingframe and its geometric features are unitary, for example, by generatingthem in a molding process. In some embodiments, the mounts comprisejoint walls and/or geometries for containing forces from both sides ofthe mounts.

In some embodiments, cartridge mount 327 comprises complementarygeometry for fitting with geometric structures in the proximal end ofcartridge 120. For example, interference elements 332, distal stop 333and snaps 334, which are further exemplified and illustrated in FIGS. 6,8A, 8B, 9 and 10.

In some embodiments, driver mount 315 comprises walls 316 defining acontaining compartment, optionally covering at least a portion of threesides of the plunger driver. In some embodiments, a forth side of theplunger driver is secured by being mechanically coupled to cartridge120. Potentially, the walls stabilize the forces generated by plungerdriver 140 and prevent its movement in at least three directions. It isa potential advantage to immobilize the plunger driver when it ismechanically coupled to the cartridge, in order to reduce movement whichwould result in movement of the cartridge. In addition, dissipatingforces close to their generating sites reduces the effect of theseforces at other sites.

In some embodiments, driver mount 317 is open topped, allowing for theplunger driver to be loaded from above. In some embodiments, due to itscoupling to cartridge 120, and since cartridge 120 is distally shifted,the geometry of driver mount 317 permits a distal translocation ofplunger driver 140, for example, by providing a walled compartment whichis bigger than the distal-proximal axis of plunger driver 140. In someembodiments, a space formed between the proximal wall and the proximalend of driver 140 is filled by an extension of the housing cover,optionally sized and/or shaped for fitting into the formed to space. Insome embodiments, gap 320 is provided to allow for a more proximalpositioning of driver 140, without mechanical interference by theproximal wall. Gap 320 is further shown and illustrated in FIG. 3B andFIG. 9.

In some embodiments, a motor mount 317 is provided, optionally inproximity to the proximal end of the cartridge which is relativelysecured. In some embodiments, motor mount is positioned laterally withrespect to driver mount 315. In some embodiments, motor mount compriseswalls 318 fitting the width of motor 170. Optionally, walls 318 compriseguiding rails 319, guiding an insertion of motor 170 into its mount 317.In some embodiments, walls 318 are not continuous and provide access fora transmission system to interconnect between the motor 170 and plungerdriver 140.

Exemplary Unitary Mounting Frame Fitted with Various Components of anAutomatic Injector

Reference is now made to FIG. 3B, an exemplary unitary mounting framefitted with some components of an automatic injector, in accordance withsome embodiments of the invention.

In some embodiments, an automatic injector device includes an actuator,for example motor 170, optionally DC motor. In some embodiments, anautomatic injector device includes transmission 302, for examplemechanically coupled to a plunger driver 140. In some embodiments, anautomatic injector device includes a power source. When the power sourceis electrically connected to motor 170, motor 170 optionally rotatesgear wheels of transmission 302 being attached to driving plunger 141 todischarge a drug.

Optionally a cartridge 120 may be installed into the device (for examplepreinstalled and/or installed by a user). In some embodiments thecartridge may include reservoir 410 optionally containing a drug and/orplugged at a proximal location with a plunger seal 140 and/or having anextension 305 and/or needle 116, optionally protected by a needle cap(not shown). Optionally plunger driver 140 may also be a part ofcartridge 120. Alternatively or additionally plunger driver 140 may bepart of the injector device.

In some embodiments, receiving frame 110 further comprises an electricmotor 170 for operating plunger 141 to empty the reservoir 410 intoneedle 116, optionally to inject fluid from the reservoir 410 into theinjection subject. In some embodiments, the motor and the reservoir haveparallel longitudinal axes, optionally typically perpendicular to theaxis of the needle at the point of injection. In some embodiments, motor170 is held to receiving frame 110 by mountings 318 and operatestransmission 302, optionally having a succession of gear wheels, toadvance plunger 141.

Exemplary Cartridge

Reference is now made to FIG. 4, illustrating an exemplary cartridgehaving distal and proximal mounting pins for connecting with a mountingframe, in accordance with some embodiments of the invention.

In some embodiments, the automatic injector cartridge comprisescomplementary geometry for fitting with the geometry provided inreceiving frame 110. For example, the proximal end of cartridge 120comprises mounting pins 425, which may engage with cavities 332 inreceiving frame 110. In some embodiments, mounting pins 425 extendbeyond the outer boundary of the body of reservoir 410. Optionally,mounting pins 425 are connected through pin connection 427, which may befor example an extended rod connecting between the pins and potentiallyproviding greater stability and strength than pins which are unrelatedto one another. In some embodiments, mounting pins 425, and optionallyconnection 427, together with their complementary geometry in thereceiving frame, determine the directionality of insertion of cartridge120 into the injector. It is a potential advantage to providedirectionality indicators such as pins 425, when using an off-centeredfluid outlet, and/or when using a bent fluid path, both defining apreferable orientation with respect to an injection subject.

In some embodiments, a distal complementary geometry is provided at thedistal end of cartridge 120. For example, distal mounting pin 422 isprovided as an extension protruding from the distal boundary of thecartridge, optionally centered. In some embodiments, pin 422 is sized tofit with fitting geometry on the proximal end of receiving frame 110.

In some embodiments, both pins 425 and pin 422 are shaped to engage withcavities which are positioned distally to the pins. This directionalityenables the loading of the cartridge by sliding it towards the distalcavities until reaching a mechanical stop. For example, until pins 425run into distal stop 333, and/or until pin 422 is fully inserted intocavity 325 and the cartridge distal wall mechanically inhibits furthermovement. Optionally, mounting pins 425 are proximally secured by snapswhich elastically deflect to allow lowering the cartridge, and snap backinto position when the mounting pins 425 are slid distally.

Exemplary Cartridge Loading into an Injector and Fitting with a UnitaryMounting Frame

Reference is now made to FIG. 5, illustrating an explosive view of anautomatic injector being loaded with a cartridge and covered with acover, in accordance with some embodiments of the invention.

In some embodiments, the injector has a base part 520 which is placed incontact with the skin of a subject to receive the injection. In someembodiments, receiving frame 110 receives and fixes cartridge 120 withinmounting plate 101. The mounting plate 101 is pivotally mounted on base520.

In some embodiments, receiving frame 110 comprises an interferenceelement 332 with a distal stop 333 and optionally snap, for exampleelastic snap lock 334. The cartridge is lowered vertically into theslide connecter, pushing down snap 334. The cartridge is then slidforward to the distal stop and upon reaching the distal stop the latchis released to latch the cartridge in place from behind against thedistal stop. The down, slide, click motion of inserting the cartridgeinto receiving frame 110 is illustrated by arrows A and B, illustratingthe downwards loading and the lateral sliding towards the distal end,respectively.

In some embodiments, cover 510 fits on mounting plate 101 over thereservoir part of the cartridge 120, after the cartridge is placed inposition, optionally having extensions, for example extension 512, forfilling in the space which is formed between plunger driver 140 andreceiving frame 110.

Exemplary Geometry and Interference Connection

Reference is now made to FIG. 6, illustrating a close-up cross-sectionalview of an exemplary geometry and interference connection of a proximalportion of a unitary mounting frame with a proximal portion of acartridge, in accordance with some embodiments of the invention.

Illustrated is a perspective view of an exemplary proximal connectorstructure, showing interference elements and snaps for mounting acartridge to a receiving frame. Optionally snaps and/or fittings and/orpins may be molded into the cartridge. For example fittings may includea plastic snap, a rivet, a pin, a cut out, an indentation, aprotuberance, snap clamps, a catch, a ball fitting, a latch, a barb etc.

In some embodiments, two interference elements are provided, for exampleinterference elements 332. It should be noted that the view illustratedin FIG. 6 shows only to one interference element 332, but another one isfound on the opposite side not shown in this view. This is applicable toall other components which are mentioned herein to include two members,but showing only one, unless mentioned otherwise.

In some embodiments, interference elements 332 are shaped to have acavity shape by covering three sides of pins 425. For example, thebottom side is covered by the receiving frame's floor 111, optionally inan offset position to the fitting from other directions, as in someembodiments, the mounting pin 425 extends along the entire length of thecartridge proximal side through connection 427, as shown in FIG. 4. Thetop side is, for example, covered by an overhanging portion ofinterference elements 332 which overhangs mounting pin 425. The distalside of the mounting pin 425 is, for example, covered with distal stop333, which in some embodiments comprised of a distal mechanicallyinterfering wall, optionally part of interfering element 332.

In some embodiments, for example, two snaps 334 latch to pins 425 tohold the proximal end of cartridge 120 to a receiving frame 110.Optionally latches 334 are flexible plastic. As cartridge 120 is loweredonto receiving frame 110, pins 425, for example see FIG. 5, pusheslatches 334 downwards, for example by elastically bending plasticlatches 334. Once cartridge 120 is in place, latches 334 snap back tosecure pins 425 from their proximal side. Alternatively or additionally,latches 334 may be made of spring steel and/or may be rigid and held bya pivot and/or spring etc.

Illustrated in FIG. 6 is an exemplary telescoping plunger driver 140.For example, plunger driver may include threaded telescoping rods suchthat when a transmission is rotated (for example by a motor) thetelescoping rods expand driving plunger seal 141 into reservoir 410and/or discharging the pharmaceutical substance out of fluid path 305.

Also illustrated in FIG. 6 are driver mount 315, having containing wallsfor containing plunger driver 140, and having gap 320 and space 620,which is formed in some embodiments between plunger driver 140 and theproximal wall of driver mount 315, and is optionally filled with coverextension 512.

Exemplary Planar Configuration

Reference is now made to FIG. 7, illustrating a perspective top view ofan exemplary side-by-side configuration of the cartridge and the drivingsystem of the cartridge, in accordance with some embodiments of theinvention.

In some embodiments, cartridge 120, plunger driver 140 and motor 170 areprovided side by side on top of receiving frame 110, potentiallyreducing the height of the injector, potentially leading to an injectorbeing held more easily by an injection subject and/or a caregiver. Insome embodiments, the components are arranged in proximity to oneanother, potentially dissipating forces in proximity to their generationsite by the containing structure of receiving frame 110.

Exemplary Cartridge Proximal Fitting

Reference is now made to FIGS. 8A and 8B, illustrating a side view of asnap fitting and immobilization of a cartridge, in accordance with someembodiments of the invention, wherein FIG. 8A illustrates across-sectional view of FIG. 8B illustrates a partial perspective view.

FIG. 8A illustrates a wide view of a side cross-section of the receivingframe 110, mounted with cartridge 120. Illustrated are distal mount 325and proximal mounting assembly, comprising interference elements 332 andsnaps 334. In some embodiments, the containing compartment 315 ofplunger driver is positioned in proximity to the proximal end ofcartridge 120.

FIG. 8B illustrates the proximal mechanical proximity of cartridge 120with plunger driver 140, when they are mechanically coupled throughplunger 141 residing in reservoir 410. Also shown in FIG. 8B is theproximity of the proximal fitting assembly of cartridge 120 withreceiving frame 110, comprising for example mounting pins 425 surroundedby interference elements 332, distal stop 333 and snaps 334. A potentialadvantage of providing a securing assembly such as the proximal fittingassembly in proximity to the plunger driver is by dissipating the forcesnear their generation site where they affect the most, and potentiallyreducing the propagation of the forces into less secured or sturdyregions of the cartridge.

Exemplary Incorporation of a Cover Extension

Reference is now made to FIG. 9, illustrating a cross-sectional sideview of the automatic injector, illustrating an incorporation of a coverextension in the immobilization system, in accordance with someembodiments of the invention.

In some embodiments, gap 320 is utilized for receiving the proximal endof plunger driver 140 before it is shifted distally by sliding beingmechanically coupled to cartridge 120, through plunger 141. Shown inFIG. 9 is gap filling by extension 512 of cover 510. In someembodiments, extension 512 provides mechanical contra for the forceexerted by the proximal portion of plunger driver 140, which resultsfrom extending the threaded telescoping rod system of plunger driver140. In some embodiments, extension 512 prevents plunger driver 140 fromshifting in a proximal direction, and enables plunger 141 to be pushedin a distal direction.

Exemplary Cartridge Distal Fitting

Reference is now made to FIG. 10, illustrating a bottom perspective viewof an exemplary unitary mounting frame, showing a distal fitting with acartridge, in accordance with some embodiments of the invention.

In some embodiments, a frame floor 111 serves as a base structure ofreceiving frame 110, and giving mechanical support for the complementaryand/or containing geometry of receiving frame 110, and also connectingbetween the geometrical features. FIG. 10 shows a bottom view of thegeometrical features as positioned on floor 111.

Shown in FIG. 10, for example, is distal mounting pin 422 fitted withdistal mount 325. In some embodiments, distal mount 325 comprises acavity sized for insertion of pin 422. Optionally, distal mount 325covers at least the top portion of pin 422, potentially balancingmechanical forces reaching from the ventral direction from inserting theneedle 116 into an injection subject. In some embodiments, distal mount325 also secures cartridge 120 by mechanically inhibiting further distalmovement of the cartridge with respect to receiving frame 110.

Also shown in FIG. 10 is a bottom view of snaps 334. In someembodiments, the floor 111 of receiving frame 110 is continuous at leastbetween the proximal end of the driving system and the distal end of thecartridge, serving as a wide mechanical platform base. Alternatively,and as exemplified in FIG. 10, floor 111 is not continuous and comprisesapertures. Optionally, at least the proximal end and/or at least thedistal end include continuous regions of floor 111. A potentialadvantage of splitting the continuous regions is that each region wouldcontain forces generated in proximity to it, and the forces wouldpropagate less to other regions.

Exemplary Dimensions of a Drug Delivery Device

In some embodiments the payload of a reservoir (for example a syringe)may include, for example between 0.5 and 2 ml and/or between 2 and 4 mland/or between 4 and 6 ml and/or between 4 and 10 ml of a drug and/ormore. In some embodiments, the injector may discharge the entire payloadas a single dose. A drug delivery device may include, for example, apatch injector, and/or an internally powered driver to drive the plungerand/or discharge the payload. For the sake of this application aninternally powered injector driver may be defined as a drive mechanismpowered by energy stored at least temporarily within the injector. Powermay be stored in a power supply, for instance as chemical potential (forexample a chemical that produces an expanding gas and/or a battery)and/or mechanical potential (for example stored in an elastic memberand/or a spring and/or a pressurized gas). For example the driver may bedesigned to discharge the payload over a time period ranging between 20and 120 seconds and/or between 120 and 600 seconds and/or between 600seconds and an hour and/or between an hour and a day and/or longer.

In general, discharge may be driven by a driver. An internally powereddriver may be powered by various mechanisms including for example amotor as discussed, including for example a DC motor, an actuator, abrushless motor, and/or a transmission including for example atelescoping assembly and/or a threaded element and/or a gear and/or acoupling and/or an elastic mechanism (for example a spring and/or arubber band) and/or an expanding gas and/or a hydraulic actuator).

A drug delivery device in accordance with some embodiments of thepresent invention may include a reservoir part as discussed. For examplea reservoir may include a medicine container and/or a syringe.Optionally a syringe may be preloaded with medicine using standardequipment and/or in an aseptic room. A preloaded syringe may optionallyinclude a proximal opening. A plunger may optionally seal the proximalopening and/or protect the sterility of the contents of the syringe. Asterile needle, typically hollow, may optionally be connected to thesyringe barrel. For example, the hollow of the needle may be in fluidcommunication with the interior of the barrel.

The needle may optionally be rigidly attached to the extension at thedistal end of the barrel. The sterility of all and/or part of the needlemay for example be protected by a sterile cover. The sterile cover mayremain on the needle when the syringe is supplied and/or installed intoan injector. For example, the medicine container may optionally includea cylindrical barrel rigidly attached to a needle. In some embodiments aplunger may slide axially along the inside of the barrel to discharge amedicine payload. For example, the medicine may be discharged throughthe hollow needle. The protruding tip of the needle may be oriented atan angle to the axis of the barrel.

An aspect ratio of the base may be defined as the ratio of the length ofthe longest axis of the base to the shortest axis. Optionally the axisratio may range between 1 to 1.5 and/or 1.5 to 2 and/or between 2 to 3and/or greater than 3. In some embodiments, the height of the injectormay range between half the length of the short axis of the base to thelength of the short axis of the base and/or between the length of theshort axis of the base to twice the length of the short axis of the baseand/or greater than the twice length of the short axis of the base. Theheight of the injector may supply leverage for pivoting the adhesive offthe skin of a patient after use.

In some embodiments, the force to insert the needle to the skin of apatient may range for example between 0.02 to 0.2 N and/or between 0.2and 0.5 N and/or between 0.5 to 5 N. Optionally, the force required toinject the drug (for example the force on a syringe plunger) may rangefor example between 5 to 60 N. For example the force required to injectthe drug may depend on the injection rate and/or the viscosity of thedrug and/or the syringe geometry and/or the needle dimensions.

In some embodiments a needle protection mechanism may be triggered by alinear force greater than, for example, between 10 to 60 N.

For example, drug delivery device may include an auto-injector. Theauto-injector may be activated by manually pushing with enough force toinsert the needle. The device may then apply an injection force toinject a drug. Once the entire drug is injected and/or when there is anobstruction and/or occlusion, the injection force may rise until itpasses a threshold triggering safeguarding of the needle and/or endinginjection.

For example in the event of an occlusion and/or at the end of delivery,the linear force generated by the device may increase to the level of upto 60 N. A needle safeguarding mechanism (for example a needleretraction mechanism) may be sensitive to the force. For example themechanism may include a snap that gives way at 40 N returning the needleto the retracted position.

In some embodiments, the stress to inject a medicine and/or to triggersafeguarding of a needle may include a torque. For example, injection ofmedicine may be driven by a plunger. The plunger may optionally bedriven by a threaded assembly, for example a threaded screw and/or teethand/or a telescoping assembly. Optionally the pitch of the teeth and/oran associated screw may range for example between 0.5 and 2 mm. Thediameter of the screw may range for example between 2.5 and 15 mm. Thetorque to power injection may range for example between 0.2 and 1.0N-cm. The trigger torque (the torque at which the needle safeguarding istriggered) may range for example between to 0.5 to 2 and/or from 2 to 4and/or from 4 to 10 N-cm.

During injection, the linear movement of a plunger may range for examplebetween 10-50 mm. The length of movement of the plunger may vary forexample with the volume of medicine to be injected that may range forexample between 0.5 to 3 ml.

In some embodiments, a safeguarding mechanism may be sensitive to atorque. For example, the needle may be retracted when the mechanism isexposed to a twisting moment. Optionally, discharge may be driven by atorque. For example the driver may apply torque to threaded elementpushing a plunger. When the torque on the driver reaches a thresholdvalue, the needle may be released and/or retracted and/or a needleshield may be deployed. Alternatively or additionally the triggermechanism may require both a torque and a linear force. For example,requiring both a torque and a linear stress may prevent prematureactivation due to momentary friction.

In some embodiments the reservoir may have a length ranging for examplebetween 20 and 42 and/or 42 and 48 mm and/or 48 and 80 mm and/or 80 and200 mm. In some embodiments an internal cylindrical space of a reservoirmay have an average width ranging for example between 1 and 3 mm and/or3 and 10 and/or 10 and 15 mm and/or 15 and 25 mm and/or 25 and 50 mm.Optionally a reservoir may have a circular cross section such that widthis the diameter of the circle. In some embodiments an extension may havea straight end portion with a length ranging for example between 1 and 3mm or 3 and 7 mm or 7 and 8 or 8 and 10 mm or 10 and 15 mm or 15 and 50mm. In some embodiments the exposed straight portion of a needle mayhave a length ranging for example between 1 and 5 mm or 5 and 7 mm or 7and 10 mm or 10 and 20 mm.

For a non-uniform cross section an average outer width may be defined asthe width of the smallest oval that can enclose the neck averaged overthe length of the neck. In some embodiments a fluid path between theextension and a reservoir cavity may include a 27 gauge needle or aneedle ranging between 25 and 30 gauge or a needle ranging between 20and 25 gauge or a needle ranging between 30 and 32 gauge. In someembodiments a needle protruding from an extension may include a 27 gaugeneedle or a needle ranging between 25 and 30 gauge or a needle rangingbetween 20 and 25 gauge or a needle ranging between 30 and 32 gauge.

General

As used herein the term “about” refers to ±25%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”.

The term “consisting of means” “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

What is claimed is:
 1. A receiving frame for immobilizing a cartridgehaving a connection feature to an automatic injector housing, thecartridge having a needle at its distal end, and is mechanically coupledin its proximal end to a plunger driver, comprising: a ventral side forfitting into a base portion of said automatic injector; and a dorsalside having: a cartridge mount for receiving said cartridge from above,said cartridge mount comprises a interference element with a distalstop, the interference element sized to slidably link to said connectionfeature and allow said cartridge to slide up to said distal stop, and asnap element allowing the interference element to receive the connectionfeature, but inhibiting disconnection of said cartridge; and a drivermount, for fixedly containing said plunger driver, said driver mountcomprising a walled container sized to at least partially surround saidplunger driver and having an open top for receiving said plunger driverfrom above; wherein said cartridge and said driver mount aremechanically coupled through said plunger driver.
 2. The receiving frameof claim 1, further comprising a motor mount, for fixedly containing amotor in operable communication with the plunger driver, said motormount comprising a walled container sized to at least partially surroundsaid motor and having an open top for receiving said motor from above.3. The receiving frame of claim 1, wherein said cartridge mount, saiddriver mount and said motor mount are made of a unitary piece.
 4. Thereceiving frame of claim 1, wherein longitudinal axes of said cartridge,said plunger driver and said motor are positioned on the same plane. 5.The receiving frame of claim 1, wherein said driver mount containsforces of at least 20 Kg*cm.
 6. The receiving frame of claim 1, whereinsaid interference fit is shaped to surround a portion of said cartridgefrom a dorsal, a distal and a ventral side of said cartridge portion. 7.A method of connecting a cartridge having a connection feature to anautomatic injector having a motor, said cartridge interconnected to aneedle at its distal end and mechanically coupled to a plunger driver atits proximal end, comprising: lowering said cartridge while beingmechanically coupled with said plunger driver into a receiving frame ofsaid automatic injector, said receiving frame having an open top;sliding said cartridge in a direction of said distal end until reachinga distal stop; linking said connection feature to an interferenceelement of said receiving frame; snapping said connection feature, suchthat disconnection of said cartridge is inhibited; and containing forcesgenerated by said plunger driver on said cartridge through saidreceiving frame, thereby immobilizing said cartridge with respect tosaid automatic injector.
 8. The method of claim 7, wherein saidcontaining forces comprises mechanically interfering with an axialtranslation of said cartridge.
 9. The method of claim 7, wherein saidcontaining forces comprises mechanically interfering with a rotationaltranslation of said cartridge.
 10. The method of claim 7, wherein saidinterlocking comprises surrounding a portion of said cartridge from atleast four directions being a dorsal side, a ventral side, a proximalside and a distal side.